| Trial ID: | L6707 |
| Source ID: | NCT03660293
|
| Associated Drug: |
Atorvastatin
|
| Title: |
Prediction and Prevention of Asymptomatic Cardiovascular Insult in Type 1 Diabetic Children: Comparative Effectiveness of Cardioprotective Drugs
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: Atorvastatin|DRUG: Captopril|DRUG: L-carnitine
|
| Outcome Measures: |
Primary: The cardiac changes induced by Simvastatin, captopril and L-Carnitine in type 1 diabetic children and adolescents., Corrected QT interval(QTc) and QT dispersion in ElectroCardioGram, before and after 4 months of receiving cardio-protective agents|The cardiac changes induced by Simvastatin, captopril and L-Carnitine in type 1 diabetic children and adolescents., Left Ventricular End Systolic Volume (ml). Left Ventricular End Diastolic Volume (ml). Ejection Fraction (EF %) and left ventricular strain using echocardiography., before and after 4 months of receiving cardio-protective agents | Secondary: The role of Troponin I levels as a cardiac marker for detection of asymptomatic cardiovascular insult in diabetic children., Serum Cardiac troponin I by Enzyme Linked ImmunoSorbant Assay, first day|The role of recent echocardiographic parameters for early detection of silent myocardial dysfunction, Echocardiography, first day|Identification of risk factors for developing diabetic cardiac insult., first day
|
| Sponsor/Collaborators: |
Sponsor: Tanta University
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
|
| Enrollment: |
150
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2017-04-01
|
| Completion Date: |
2019-06-01
|
| Results First Posted: |
|
| Last Update Posted: |
2019-06-17
|
| Locations: |
Faculty of Medicine- Tanta University, Tanta, Gharbia, 0000, Egypt
|
| URL: |
https://clinicaltrials.gov/show/NCT03660293
|
